ECG Patient Cable
by Biomedical Instruments Co., Ltd. 40 variants
Ref 05A20Model PL-U3A,PL-U3B,PL-U3C,PL-U3D,PL-B3A,PL-B3B,PL-B3C,PL-B3D,PL-M3A,PL-M3B, PL-M3C, PL-M3D,10A16,10E16,10A17,10A21,10E21,07A13,07E13,07A14,07E14,07A21,05S13,05E14,05S14,05A20,05E20,05S22,05S24,04S10,04S11,04S21,04S22,03S21,10E44,10E45,10E46,10E47,10E48,10E49
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697091208PL22 06970912083344 | Date16 Jun 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- PL-U3A, PL-U3B, PL-U3C, PL-U3D, PL-B3A, PL-B3B, PL-B3C, PL-B3D, PL-M3A, PL-M3B, PL-M3C, PL-M3D, 10A16, 10E16, 10A17, 10A21, 10E21, 07A13, 07E13, 07A14, 07E14, 07A21, 05S13, 05E14, 05S14, 05A20, 05E20, 05S22, 05S24, 04S10, 04S11, 04S21, 04S22, 03S21, 10E44, 10E45, 10E46, 10E47, 10E48, 10E49
- Primary DI / UDI-DI
- 06970912083344
- Basic UDI-DI
- 697091208PL22
- EMDN Code
- Z12050485 Holter system instruments for cardiovascular parameters - consumables
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000016483
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Biomedical Instruments Co., Ltd.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No